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How it works

The living blueprint of your clinical trial.

Cori reads your protocols, RFPs and past trials into one versioned record, the Knowledge Hub, enriched with trusted external sources. Feasibility, design, risks, the bid and budget, submissions and review all work from it, before the trial starts and while it runs, and each saves its decision back.

Book a demoSee the modules
  • ISO/IEC 27001 certified
  • GxP aligned
  • Hosted in your region

Knowledge Hub

Mapped to CDISC USDM v4.0.

  • Feasibility and strategyScenario chosen
  • Design and SoADesign chosen
  • Trial risksOwners set
  • Bid and budgetBudget agreed
  • Regulatory packageDrafting
  • Compliance reviewNext
Each module reads what the others decided, in any order, and saves its own decision back.

The modules

Every module starts from what the others already decided.

Feasibility and strategy

Build the strategy on what comparable trials did.

The challenge

Country and site choices often rest on a few people's memory of past trials, and the evidence behind a strategy is hard to show to the sponsor or the rest of the team.

Cori drafts the ways the trial could run and scores each against comparable trials, yours and those in curated registries.

SCORED ON PRECEDENTA6 countries, 48 sites41 trialsB4 countries, 36 sites18 trialsC8 countries, 60 sites3 trialsScenario B, but add PolandB2B, adding Poland22 trialsScenario B2 chosen, reasons kept
Sample study

What it changes

  • Scenario planning

    Several ways the trial could run, side by side.

  • Your ideas, tested the same way

    Describe a change in plain words. The original stays, and your variant is scored against the same evidence.

  • A strategy you can defend

    Each score shows the trials behind it, and says so when there are none.

Design and SoA

Design the trial you can deliver.

The challenge

Designs are usually judged on the science first. Their cost, duration and burden on sites and participants show up later, when they are expensive to change.

Compare design options on duration, cost and site burden, not only on endpoints.

SCHEDULE OF ASSESSMENTSV1V2V3V4V5V6V7V8Physical examVital signsLabsECGImagingQoLA · 24 moB · 21 moC · 18 mo4 fewer assessments, cost updated
Sample study

What it changes

  • Fewer surprises later

    Recruitment, startup time and outcomes from registries and your own delivered trials.

  • Cost and burden, seen while it is still a choice

    Duration, visits per participant, cost and endpoint risk, side by side.

  • One schedule, everything follows

    Edit the visit grid in place. The budget and the documents follow it.

Trial risks

See the risks before you commit.

The challenge

Risk registers are often filled in from experience and revisited rarely, so a risk is found when it lands rather than while there is time to plan around it.

Each risk is scored on how often it appeared in comparable trials, when it landed and what it cost.

LIKELIHOODIMPACTEthics timeline, CzechiaMitigation and owner setCentral lab contractMitigation and owner setCompeting trials, SpainMitigation and owner setDrug import licenceMitigation and owner setComparable trials checked
Sample study

What it changes

  • Risks found while there is time to act

    Each risk comes with how it played out on comparable trials, yours or public ones.

  • Scores you can trace

    Likelihood and impact come from comparable trials and regulatory findings.

  • Flagged again when things change

    Each risk has an owner and a plan. When the design or the regulations change, Cori flags the risks that change with them.

Bid and budget

A budget that moves when the design does.

The challenge

Bids are priced under time pressure from spreadsheets and memory, and each line is hard to defend when the sponsor pushes back.

The site budget is projected from the Schedule of Assessments. CROs price each bid line on trials they delivered, with public benchmarks where their own data is thin.

PRICED ON COMPARABLESSERVICEEVIDENCEPRICEDSite management3 comparable trialsEUR 1.84MData management5 comparable trialsEUR 0.92MMonitoring4 comparable trialsEUR 2.11MMedical writing6 comparable trialsEUR 0.26MTotalEUR 5.13M
Sample study

What it changes

  • Bids you can defend

    Each bid price shows the comparable trials it came from.

  • Per site and per country

    Site and country budgets are broken out from the same schedule.

  • Every negotiation round kept

    Each round is a snapshot, so you can show what changed and why.

FSP bids

CROs price dedicated roles on their own grades.

When a CRO places dedicated staff with a sponsor, Cori reads the sponsor's job descriptions and maps each role to the CRO's grades, with its reasoning shown. The rate card by role and country is built from its grade cost bands and checked against the rates it won at, restated to today's terms, with lost bids alongside.

ROLES TO YOUR GRADESRATE CARD, USD/HUSPLESCRA II, OncologyG4Site ManagerSenior CRA scopeG5Data Manager IIG4CRA II1185872Sr CRA1427490CDM1125466Escalator trails PL wagesChecked against past won and lost rates
Sample study

What it changes

  • Graded on scope

    A Site Manager role with Senior CRA scope is graded and priced for that scope, so the rate matches the work asked for.

  • Contract terms in the margin

    The escalator, USD rates with no FX clause, and vacancy and backfill cost, each shown in contribution margin before the bid goes out.

  • Past bids, with the debrief

    Each bill rate sits beside the FSP rates won and lost before, with the sponsor's debrief attached.

Regulatory package

The package for every country, from one blueprint.

The challenge

Every country needs its own documents and translations, all consistent with the protocol. Keeping them aligned by hand is slow, and gaps are often found late.

Cori drafts the protocol on your templates, then the consent form, submission documents and each country's pack, and names the gaps while there is time to close them.

PROTOCOL FIRST, THEN THE RESTProtocolConsent formSynopsisCover letterCOUNTRY PACKSPLTranslatedESTranslatedDETranslatedCZTranslatedREADYProtocol, submission documents, 4 country packs

What it changes

  • Protocol first, everything consistent

    Drafted from the design, the schedule and the decisions already made, with the consent form and submission documents kept consistent with it.

  • Every country covered

    The local documents each country needs, including Part II for each EU member state.

  • Translations that keep their format

    Each document translated for its country, with structure and formatting kept.

Compliance review

Reviewed against your SOPs and the rules that apply.

The challenge

Reviewers check each document by hand against regulations, guidance and SOPs, and findings live in email threads and tracked changes.

Each draft is checked against ICH GCP, the regulations of each trial country, your SOPs and the rest of the record. Findings are pinned to their passage, and nothing moves on until a reviewer signs it off.

YOUR SOPRESOLVEDVisit window widerthan your SOP allowsGCPRESOLVEDConsent form versionis out of dateDESIGNOPENDose differs fromthe approved design3 findings, each attached to its passage. 2 resolved.

What it changes

  • Your standards, every time

    Every draft is checked against your own standards.

  • The rules that apply, checked

    ICH GCP, the EU Clinical Trials Regulation, FDA regulations and national law in each trial country.

  • Documents that agree with each other

    Flags where a document disagrees with the design, the schedule or another document.

Built into every module

A change reaches every module, and the reasoning stays.

Amendments

Change once. See everything it touches.

The challenge

One amendment can touch many documents, country packs, budget lines and dates. Finding them all by hand is slow, and anything missed becomes rework or unbillable work.

Once an amendment is approved, Cori redrafts the affected sections and, for CROs, the change order.

Protocol6 sectionsConsent formRedraftedSoA2 visits addedBudget+ EUR 214kTimelineFPI + 2 weeksCountry packs3 to refileAMENDMENTEndpoint addedCHANGE ORDERPriced, with past changes as evidence

What it changes

  • Impact before commitment

    Every affected document, cost and date, listed before anyone agrees to the change.

  • Redrafted for your review

    Your team reviews redrafted sections instead of editing each document and country pack by hand.

  • Change orders with evidence

    Each one carries the design change behind it and comparable changes from your history.

Decision records

Each decision is saved with its evidence and the person who approved it.

The challenge

The reasoning behind a decision usually lives in meeting notes and inboxes, and leaves with the people who made it.

Every step records the question, the options considered, the evidence and the approver.

KEPT ACROSS TRIALSTRIAL 1Scenario chosenTRIAL 1Design option CTRIAL 1Budget agreedTRIAL 2Site risk planTRIAL 2Consent form approvedTRIAL 2Change order pricedTRIAL 3Scenario chosenTRIAL 3Submission approvedTRIAL 3Review signed off9DECISION RECORDSTrial 3Starts with 6 recordsEach record keepsthe question,options, evidenceand approver.

What it changes

  • Recorded as you work

    Captured where the decision is made, with no separate log to keep.

  • Read by every step

    Budget, documents and review start from the decisions already made.

  • Your organisation's memory

    The next trial can look up what was decided before and how it turned out.

The record itself

Every value shows where it came from.

Each field shows whether a person, a file or Cori supplied it, and earlier versions stay on record.

Example study. The screens, field names and source marks are the product’s.

The structured record of a trial in Cori, each field showing the document and section its value came from, alongside the version history.
Every field shows the document and section its value came from.Sample study
The Schedule of Assessments in Cori as an editable grid of assessments by visit, with one visit window flagged where it disagrees with the protocol.
The visit grid, edited in place, with a window flagged where it disagrees with the protocol.Sample study

Where Cori sits

Works alongside the systems you already run.

Your CTMS, RIM, eTMF and document systems stay the systems of record. Cori keeps the blueprint beside them, with every value traced to its source.

Your systems of record

  • CTMS
  • RIM
  • eTMF
  • Document systems

Cori, alongside them

The living blueprint of the trial, with its drafts and decisions.

They stay as they are. Nothing to replace.

Your data, your decisions

Your trial runs in its own environment.

Your own environment

Each customer has its own deployment, hosted in its region. Your data is never used to train models.

Cori drafts, a person decides

Nothing is applied until someone approves it. When Cori cannot find a source, it asks.

Every value traces back

Each value shows who supplied it: a person, a file or Cori. Earlier versions too.

Certified, and every action logged

ISO/IEC 27001 certified, with EU, US and UK data residency. An altered log entry shows.

Security and compliance

See what it changes for your team.

See it on a trial of your own.

Book a demo with us.

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